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Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial (ReSET)

Primary Purpose

Hypertension

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Renal artery ablation

Renal angiography

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Treatment Resistant Hypertension

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion Criteria:

Pregnancy
Non compliance
Heart Failure (NYHA 3-4)
LV ejection fraction < 50 %
Renal insufficiency (eGFR<30)
Unstable coronary heart disease
Coronary intervention within 6 months
Myocardial infarction within 6 months
Claudication
Orthostatic syncope within 6 months
Secondary Hypertension
Permanent atrial fibrillation
Significant Heart Valve Disease
Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
Second and third degree heart block
Macroscopic haematuria
Proximal significant coronary stenosis
Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)

Sites / Locations

Skejby Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Renal artery ablation

Sham

Arm Description

By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.

By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.

Outcomes

Primary Outcome Measures

daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement

Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.

Secondary Outcome Measures

ambulatory 24 hours BP measurements

Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.

Echocardiography

Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.

Biomarkers

Biomarkers concerning renal sodium excretion

Applanation tonometry

Pulse wave velocity, augmentation index, central BP estimates

forearm plethysmography

Forearm minimum vascular resistance

Full Information

NCT ID

NCT01459900

First Posted

October 24, 2011

Last Updated

September 19, 2016

Sponsor

Aarhus University Hospital Skejby

Collaborators

Aarhus University Hospital, Regionshospitalet Silkeborg, Randers Regional Hospital, Regional Hospital Holstebro, Central Jutland Regional Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01459900

Brief Title

Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Acronym

ReSET

Official Title

Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aarhus University Hospital Skejby

Collaborators

Aarhus University Hospital, Regionshospitalet Silkeborg, Randers Regional Hospital, Regional Hospital Holstebro, Central Jutland Regional Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Treatment Resistant Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal artery ablation

Arm Type

Active Comparator

Arm Description

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.

Intervention Type

Procedure

Intervention Name(s)

Renal artery ablation

Intervention Description

Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.

Intervention Type

Procedure

Intervention Name(s)

Renal angiography

Intervention Description

Renal angiography by femoral access.

Primary Outcome Measure Information:

Title

daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement

Description

Time Frame

3 months follow up

Secondary Outcome Measure Information:

Title

ambulatory 24 hours BP measurements

Description

Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.

Time Frame

1, 3 and 6 months

Title

Echocardiography

Description

Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.

Time Frame

6 months

Title

Biomarkers

Description

Biomarkers concerning renal sodium excretion

Time Frame

1 months

Title

Applanation tonometry

Description

Pulse wave velocity, augmentation index, central BP estimates

Time Frame

6 months

Title

forearm plethysmography

Description

Forearm minimum vascular resistance

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs. Exclusion Criteria: Pregnancy Non compliance Heart Failure (NYHA 3-4) LV ejection fraction < 50 % Renal insufficiency (eGFR<30) Unstable coronary heart disease Coronary intervention within 6 months Myocardial infarction within 6 months Claudication Orthostatic syncope within 6 months Secondary Hypertension Permanent atrial fibrillation Significant Heart Valve Disease Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH Second and third degree heart block Macroscopic haematuria Proximal significant coronary stenosis Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole N Mathiassen, MD, PhD

Organizational Affiliation

Aarhus University Hospital, Dep. Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skejby Hospital

City

Aarhus

State/Province

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28830251

Citation

Peters CD, Mathiassen ON, Vase H, Bech Norgaard J, Christensen KL, Schroeder AP, Rickers HJVH, Opstrup UK, Poulsen PL, Langfeldt S, Andersen G, Hansen KW, Botker HE, Engholm M, Bertelsen JB, Pedersen EB, Kaltoft A, Buus NH. The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial). Blood Press. 2017 Dec;26(6):366-380. doi: 10.1080/08037051.2017.1368368. Epub 2017 Aug 23.

Results Reference

derived

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Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

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